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A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Status
Active
Cancer Type
Hematopoietic Malignancies
Lymphoma
Non-Hodgkin Lymphoma
Unknown Primary
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06624085
Protocol IDs
GO44900 (primary)
Study Sponsor
Hoffmann-La Roche

Summary

The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in
participants in the United States, including under-represented racial and ethnic
populations, that have relapsed or refractory (R/R) diffuse large B-cell lymphoma
(DLBCL).

Eligibility

  1. Histologically confirmed DLBCL, not otherwise specified (NOS)
  2. Relapsed (disease that has recurred following a response that lasted = 6 months after completion of the last line of therapy) or refractory ( disease that did not respond to or that progressed < 6 months after completion of the last line of therapy) disease
  3. At least one prior line of systemic therapy
  4. Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)
  5. At least one bi-dimensionally measurable (> 1.5 cm) nodal lesion, or one bi-dimensionally measurable (> 1 cm) extranodal lesion, as measured on CT scan
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.